Cleared Traditional

Sealer Solvent

K241354 · Inter-Med, Inc. · Dental
Aug 2024
Decision
106d
Days
—
Risk

About This 510(k) Submission

K241354 is an FDA 510(k) clearance for the Sealer Solvent, a Cleanser, Root Canal, submitted by Inter-Med, Inc. (Racine, US). The FDA issued a Cleared decision on August 27, 2024, 106 days after receiving the submission on May 13, 2024. This device falls under the Dental review panel.

Submission Details

510(k) Number K241354 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2024
Decision Date August 27, 2024
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KJJ — Cleanser, Root Canal
Device Class —